BRAINLAB Curve; Model/catalogue (article) numbers for Curve: 19901; 19901B; 19900; 19905 UDI (GTIN) for Curve: 04056481138011
Reported: August 19, 2020 Initiated: July 16, 2020 #Z-2792-2020
Product Description
BRAINLAB Curve; Model/catalogue (article) numbers for Curve: 19901; 19901B; 19900; 19905 UDI (GTIN) for Curve: 04056481138011
Reason for Recall
Incorrect manufacturer calibration
Details
- Recalling Firm
- Brainlab AG
- Units Affected
- 18 units
- Distribution
- USA: CA, TX, RI OUS: Armenia; Australia; Brazil; Bulgaria; Canada; Finland; France; Germany; Hong Kong; India; Israel; Italy; Japan; Mongolia; Morocco; Spain
- Location
- Munich, N/A
Frequently Asked Questions
What product was recalled? ▼
BRAINLAB Curve; Model/catalogue (article) numbers for Curve: 19901; 19901B; 19900; 19905 UDI (GTIN) for Curve: 04056481138011. Recalled by Brainlab AG. Units affected: 18 units.
Why was this product recalled? ▼
Incorrect manufacturer calibration
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 19, 2020. Severity: Moderate. Recall number: Z-2792-2020.
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